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Effects of Pentazocine Versus Lorazepam or Placebo on Manic Symptoms

This study has been completed.
Sponsor:
Collaborator:
Stanley Medical Research Institute
Information provided by (Responsible Party):
Beth L. Murphy MD, PhD, Mclean Hospital
ClinicalTrials.gov Identifier:
NCT00431184
First received: February 1, 2007
Last updated: April 20, 2012
Last verified: April 2012
History of Changes
  Purpose

Pilot data indicates that pentazocine decreases manic symptoms in hospitalized individuals. To follow up these initial findings, we plan to conduct a larger, more rigorous, double-blind study. We will examine whether pentazocine, an agent with kappa-opiate activity, decreases manic symptoms.


Condition Intervention Phase
Bipolar Disorder
Schizoaffective Disorder
Manic Disorder
Mania
Manic State
 Drug: pentazocine
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Pentazocine Versus Lorazepam or Placebo on Manic Symptoms

Resource links provided by NLM:

MedlinePlus related topics: Bipolar Disorder
U.S. FDA Resources

Further study details as provided by Mclean Hospital:

Primary Outcome Measures:
  • Mania Acute Rating Scale [ Time Frame: hourly-daily ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Young Mania Rating Scale [ Time Frame: daily ] [ Designated as safety issue: No ]

Enrollment: 20
Study Start Date: January 2007
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
ativan
 Drug: pentazocine
pentazocine as Talwin NX 50mg po twice
Placebo Comparator: 2
placebo
 Drug: pentazocine
pentazocine as Talwin NX 50mg po twice

Detailed Description:

Dysregulation of the opioid system may underlie the pathophysiology of mood disorders, such as bipolar disorder. Drugs that modulate the opioid system might be effective treatments for bipolar disorder. The profile and actions of the kappa-opioid system make drugs that target this system particularly promising as a treatment modality, with relatively low risk of addictive properties. Pentazocine is an approved drug for pain relief with a good side effect profile. It is predominantly a kappa opioid agonist with weaker side effects at mu opioid receptors, at which it is an antagonist. Data from our open-label pilot study of pentazocine had promising results. We will follow up on these findings with a double-blind, placebo, and active-control study of individuals with bipolar disorder or schizoaffective disorder who are currently hospitalized with acute mania. The antimanic effects of pentazocine will be compared with a placebo control at one site, and with an active control (ativan)at the second site.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • bipolar or schizoaffective disorder
  • currently manic
  • no acute medical issues
  • no substance withdrawal

Exclusion Criteria:

  • unable to give informed consent
  • using opiates for pain management
  • history of head injury, dementia, or mental retardation
  • seizure disorder
  • glaucoma
  • unstable cardiac condition or arrhythmia
  • moderate-severe pulmonary disease
  • pregnancy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00431184

Locations
United States, Massachusetts
McLean Hospital
Belmont, Massachusetts, United States, 02478
United States, New Jersey
Jersey Shore Psychiatric Associates
Neptune, New Jersey, United States, 07753
Sponsors and Collaborators
Mclean Hospital
Stanley Medical Research Institute
Investigators
Principal Investigator: Beth L Murphy, MD/PhD Mclean Hospital
  More Information

Additional Information:
McLean hospital website, with links to research.  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: Beth L. Murphy MD, PhD, Principal Investigator, Mclean Hospital
ClinicalTrials.gov Identifier: NCT00431184     History of Changes
Other Study ID Numbers: 2006-P-002344
Study First Received: February 1, 2007
Last Updated: April 20, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Mclean Hospital:
bipolar disorder
bipolar mania
schizoaffective disorder
schizoaffective mania
 mania
kappa opiates
opiates

Additional relevant MeSH terms:
Bipolar Disorder
Psychotic Disorders
Affective Disorders, Psychotic
Mood Disorders
Mental Disorders
Schizophrenia and Disorders with Psychotic Features
Lorazepam
Pentazocine
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
 Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Analgesics, Opioid
Analgesics
Sensory System Agents
Adjuvants, Anesthesia

ClinicalTrials.gov processed this record on May 16, 2013